A Trial Looking at Treating Dry Mouth After Radiotherapy for Head and Neck Cancer

NCT02941276 | Completed DMC

• 1 other identifier: 11/0138
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief Summary

This trial is looking at using an intra-oral electrostimulating device for the management of radiotherapy-induced dry mouth.

Conditions

Xerostomia; Head and Neck Neoplasms

Outcome Measures

Primary Outcomes (1)

• Improvement of subjective perception of dry mouth as measured on the Visual Analog Scale

  The primary outcome is defined as the proportion of patients reporting a 30% reduction of xerostomia symptoms as evaluated through a 100mm VAS (100mm=maximum dryness).

  12 month

Secondary Outcomes (5)

• Salivary function

  12 month

• Head and Neck cancer Quality of Life

  12 month

• Oral Health Quality of Life

  12 month

• General quality of Life

  12 month

• Participant compliance

  12 month

Study Arms (2)

Group A

EXPERIMENTAL

Active electrostimulator device (intra-oral active second generation Saliwell GenNarino) (Saliwell Ltd., Harutzim, Israel)

Device: Active Electrostimulator device

Group B

SHAM COMPARATOR

Sham electrostimulator device (intra-oral sham second generation Saliwell GenNarino) (Saliwell Ltd., Harutzim, Israel)

Device: Sham Electrostimulator device

Interventions

Active Electrostimulator device DEVICE

Patients who will receive a fully functioning device

Group A

Sham Electrostimulator device DEVICE

Patients who will receive a device that does not release electric stimuli (but provided mechanical/tactile stimulation)

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be at least 18 years old
• To have received more than 40 Gy of external beam RT for cancer in the H\&N region at least 4 months before entry into the study
• To have grade 1 or 2 of RTOG/EORTC Late Radiation Morbidity Scoring Schema
• To have a degree of minimum degree of dryness of 50mm (≥50mm) on a 100mm VAS scale (0=no dryness; 100
• =maximum dryness).
• To have demonstrable residual salivary gland function (increase in salivary flow on appropriate stimulation (e.g. chewing paraffin wax)
• To have at least one parotid gland

You may not qualify if:

• To have severe uncontrolled systemic disease (on the basis of the classification of the American Society of Anesthesiology: ASA IV and ASA V)
• To have known allergy to materials similar to those used in the investigational product
• To wear other active implants such as cardiac pacemaker or defibrillator, or hearing aids
• To have an unstimulated whole salivary flow of 0ml/15min (complete absence of unstimulated salivary flow as measured via sialometry for 15 minutes).
• To use of pilocarpine as systemic therapy
• To have grade 3 RTOG/EROTC or no resting saliva (sialometry = 0mL/1.5 min)
• To have no parotid glands

Sponsors & Collaborators

• University College, London: lead

MeSH Terms

Conditions

Xerostomia; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms

Study Officials

• Dr Stefano Fedele, PhD

  University College, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2016
• First Posted: October 21, 2016
• Study Start: November 1, 2011
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: November 3, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share